Efficacy and Safety of 1565-nm Non-ablative Fractional Laser Versus Long-pulsed 1064-nm Nd:YAG Laser in the Treatment of Enlarged Facial Pores
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Subjective evaluations for improvement in appearance of facial pores
研究概览
简要总结
Facial pores are visible openings of pilosebaceous follicles, it is one of the important factors that affect the appearance of facial skin. This study aims to evaluate and compare the Efficacy and safety of 1565 nm non-ablative fractional laser (NAFL) and long-pulsed 1064 nm Nd:YAG laser (LPNY) in the treatment of enlarged facial pores.
详细描述
Facial pores are visible openings of pilosebaceous follicles. These openings are not fixed structures and they can be affected by many factors, including sebum secretion, skin elasticity, hair thickness, age, hormones and ultraviolet exposure. These enlarged pores remain a cosmetic problem that impacts patient quality of life. At present, there is no unified evaluation standard for enlarged facial pores, and the mechanisms that underline enlarged facial pores remain unclear.
Various methods have been used to treat enlarged facial pores mainly focus on the possible causes. Treatment options include topical retinoic acid, oral isotretinoin, antiandrogen therapy, injections of botulinum toxin type A, chemical peeling, lasers, radiofrequency, and ultrasound devices. In recent years, various studies on laser treatments of facial pores are gradually increasing because of good efficacy and limited adverse reactions.
The 1064-nm LPNY has been widely used for facial rejuvenation. Many studies have confirmed that LPNY can reduce facial wrinkles and improve skin elasticity. Some researchers have used it to treat enlarged pores, and it has shown good results. Recently, 1565-nm NAFL is introduced for skin resurfacing, it has also been shown to be effective in treating enlarged facial pores. However, there are not enough clinical researches to confirm their efficacy, and no study has compared these two laser treatments before. So this is the first self-comparative study to compare the safety and efficacy of two lasers in the treatment of enlarged facial pores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •subjects with enlarged facial pores who were screened by a designated dermatologist
排除标准
- •infectious skin disease or systemic disease; skin tumors; pregnancy and lactation; patients with a history of glucocorticoids, immunosuppressant drugs and other drugs within 4 weeks; a history of keloid; a medical history of chemical peelings, filler injections, plastic surgery, or laser therapy on the face in the last 3 months
结局指标
主要结局
Subjective evaluations for improvement in appearance of facial pores
时间窗: two months after last treatment(T1)
Subjects were asked to evaluate the improvement of pore appearance after each treatment and follow-up, rated on a 4-point grading scale. 0=No significant change (0-10%); 1=Mild improvement (11-25%); 2=Moderate improvement (26-50%); 3=Marked improvement (51-75%); 4=Very significant improvement (76-100%).
Change from baseline in Pore number
时间窗: from baseline(T0) at two months after last treatment(T1)
The VISIA Complexion Analysis System was used to take photos of both facial sides. The system can automatically measure the number of pores. When pore size is smaller or less visible, the system will not detect it, and the pore count will be lower.
Satisfaction evaluations for treatment results
时间窗: two months after last treatment(T1)
Subjects rated their satisfaction with the treatment results, using a Likert satisfaction scale (1-5). 1=Very dissatisfied; 2=Dissatisfied; 3=Neither satisfied nor dissatisfied; 4=Satisfied; 5=Very satisfied.
次要结局
- Pain score(immediately after each laser treatment)
- Side effects(through study completion, an average of 0.5 year)